VB119 for Focal Segmental Glomerulosclerosis

No longer recruiting at 8 trial locations

Overseen By Project Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tenet Medicines

Must be taking: Prednisone

Disqualifiers: Diabetes, SLE, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 39 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called VB119 to determine if it helps individuals with certain kidney conditions, specifically primary Minimal Change Disease (MCD) or primary Focal Segmental Glomerulosclerosis (FSGS), remain in remission. Researchers aim to assess whether VB119 can safely maintain remission and extend the duration of response in those who previously responded to steroid treatments. It suits adults who have had a kidney biopsy confirming primary MCD or FSGS, have responded to steroids in the past, and currently exhibit significant protein in their urine despite reducing steroids. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of prednisone (a type of steroid) of no more than 20 mg/day for at least 14 days before starting the trial.

Is there any evidence suggesting that VB119 is likely to be safe for humans?

Research has shown that VB119 has been tested in people before, and results indicate it is generally safe. In earlier studies, participants took VB119 without major problems, and no serious side effects were reported. This suggests that VB119 is usually well-tolerated by those who have used it.

The current trial focuses on evaluating both the effectiveness and safety of VB119. At this stage, researchers are examining its safety in more people. While specific details about side effects are not available here, further testing of VB119 suggests it has shown positive results in earlier tests. Prospective participants might find this information reassuring regarding its safety so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for FSGS?

Researchers are excited about VB119 for treating focal segmental glomerulosclerosis (FSGS) because it represents a novel approach compared to standard treatments like corticosteroids and immunosuppressants. VB119 is unique because it is administered intravenously and targets the immune system in a more precise manner, potentially reducing the inflammation and scarring in the kidneys without the broad side effects associated with current options. This targeted mechanism of action holds promise for improved outcomes and fewer side effects for patients with FSGS.

What evidence suggests that VB119 might be an effective treatment for FSGS?

Research has shown that VB119, the investigational treatment in this trial, could be promising for treating focal segmental glomerulosclerosis (FSGS), a kidney disease. Studies suggest it might prevent the disease from worsening after initial improvement. VB119 targets parts of the immune system that cause kidney damage. Early findings indicate it could lower protein levels in urine, which is important for kidney health. Although more research is needed, these early results offer hope for its potential effectiveness in managing FSGS. ^{1 3 5 6 7}

Who Is on the Research Team?

Keenan

Principal Investigator

ValenzaBio, Inc.

Are You a Good Fit for This Trial?

Adults over 18 with a kidney biopsy-proven diagnosis of primary MCD or FSGS within the last 10-20 years, who responded to steroids before and have had significant proteinuria in the past 2 years. Participants must be on a stable prednisone dose and have controlled blood pressure. Women must be non-childbearing or use contraception; men agree not to donate sperm for 4 months post-trial.

Inclusion Criteria

My kidney condition improved completely after using steroids.

I agree not to donate sperm for 125 days after my last dose of the study drug.

I am on prednisone, expected to reduce to ≤20 mg/day for 2 weeks before starting.

Exclusion Criteria

Has an absolute neutrophil count <1.5 x 10/L

I have an ongoing infection, such as TB, hepatitis, HIV, or a UTI.

I have type 1 or type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VB119 100 or 200mg IV doses administered 4 times

39 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VB119

Trial Overview The trial is testing VB119's effectiveness in maintaining remission and prolonging response duration in adults with primary MCD or FSGS who previously responded to steroid therapy. It's a Phase 2 study across multiple centers, focusing on those who've seen benefits from steroids.

How Is the Trial Designed?

Group I: VB119 Experimental Treatment 1 Intervention

VB119 100 or 200mg IV doses administered 4 times

Who Is Running the Clinical Trial?

Tenet Medicines

Lead Sponsor

Trials

3

Recruited

7+

ValenzaBio, Inc.

Lead Sponsor

Trials

3

Recruited

60+

ACELYRIN Inc.

Lead Sponsor

Trials

9

Recruited

1,100+

Citations

1. academic.oup.com academic.oup.com/ndt/article/39/4/569/7606323

Management of adult patients with podocytopathies A summary of ongoing trials in minimal change disease and focal segmental glomerulosclerosis, including the phase of the trial, inclusion of disease entity, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05441826

Efficacy and Safety of VB119 in Subjects With Minimal ... Phase 2, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11812565/

Advances in Focal Segmental Glomerulosclerosis ... A recent study has reported the clinical trial results of using the urinary MCP-1 and TIMP-1 as biomarkers to predict the TNF-α activation in ...

4. withpower.com withpower.com/trial/phase-2-nephrosis-lipoid-4-2022-73f1e

VB119 for Focal Segmental Glomerulosclerosis This trial is testing a new treatment called VB119 to see if it can help keep certain kidney diseases under control. It focuses on adults with specific ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468024922018162

Novel Treatment Paradigms: Focal Segmental ... Traditionally, in glomerular disease clinical management and trials, a complete remission has been a reduction of proteinuria to <0.3 g/d with a stable serum ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9831941/

Focal Segmental Glomerulosclerosis - PMC - PubMed Central Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: a prespecified analysis of the dapagliflozin and prevention of ...

7. go.drugbank.com go.drugbank.com/drugs/DB19316/clinical_trials?conditions=DBCOND0038485%2CDBCOND0044791&phase=2&purpose=treatment&status=terminated

Budoprutug Terminated Phase 2 Trials for Focal ... Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS). Budoprutug (DB19316). Sign up for a ...